NCT03431740终止不适用
Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in diffusing capacity for nitric oxide (DLNO)
研究概览
简要总结
The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
- •signed informed consent of the participant
排除标准
- •thoracic RT in the past
- •treatment with immune checkpoint inhibitors
- •unstable condition affecting participation in the measurements
结局指标
主要结局
Change in diffusing capacity for nitric oxide (DLNO)
时间窗: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
次要结局
- Transfer Coefficient for nitric oxide (DLNO/VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Alveolar Volume (VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Pulmonary capillary blood volume (Vc)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Forced expiratory flow between 25% and 75% of forced vital capacity(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Transfer Coefficient for carbon monoxide (DLCO/VA)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Ratio of DLNO and DLCO(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Tissue concentration of nitric oxide of the airway wall (CawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Forced expiratory volume in 1 second(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Diffusing capacity for carbon monoxide (DLCO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Total flux of nitric oxide in the conducting airway compartment (JawNO)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
- Forced vital capacity(Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT)
研究者
研究点 (1)
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